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Digoxin In Treatment of Alcohol Associated Hepatitis

NCT05014087 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-10-09

No results posted yet for this study

Summary

Prospective, single center, open label, randomized controlled trial to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients with acute alcohol associated hepatitis, digoxin administration and dose adjustment.

The study intervention will be intravenous digoxin (renal-based dosing for maximum of 28 days) versus no digoxin in an open-label 1:1 randomized allocation of patients with severe acute alcohol associated hepatitis.

Conditions

  • Acute Alcoholic Hepatitis
  • Chemical and Drug Induced Liver Injury
  • Alcohol-Induced Disorders
  • Steatohepatitis Caused by Ingestible Alcohol

Interventions

DRUG

Intravenous digoxin

Loading dose: the total loading dose of digoxin will be determined using the Loading nomogram. The FDA-recommended total IV digoxin loading dose range is 8 to 12 mcg/kg. The lowest recommended dose of 8 mcg/kg was used in constructing the digoxin Loading nomogram that will be used in this trial. Maintenance dose: the maintenance dose will be started approximately 24 hours after initiation of digoxin loading. The post-loading digoxin trough will be reviewed prior to starting maintenance dosing. Subjects on P-gp inhibitors or spironolactone, will have an additional digoxin level performed 12-hours after any dose adjustment. Once digoxin levels are stable, 24-hour blood draws will be performed.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Bubu Banini, MD, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2025-06-22
Completion
2025-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05014087 on ClinicalTrials.gov